AstraZeneca and Ionis Receives the US FDA’s Approval for Wainua (eplontersen) to Treat Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis
Shots:
- The approval was based on the P-III (NEURO-TTRansform) clinical trial evaluating the safety & efficacy of Wainua vs PBO in patients with ATTRv-PN (Stage 1 or 2)
- The results portrayed that patients treated with Wainua depicted consistent & sustained benefits on co-primary endpoints (serum TTR concentration & neuropathy impairment measures by mNIS+7) & key secondary endpoints of QoL on Norfolk QoL-DN. These results were published in the JAMA
- Following AstraZeneca & Ionis’ global development & commercialization agreement, both companies will commercialize Wainua across the US & will seek regulatory approval in the EU& other parts of the world. The company expects to make Wainua available in the US market by Jan 2024
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
